Policy
The US dramatically altered its recommendations for a series of vaccines, which drive billion-dollar earnings for giants like Merck and Pfizer.
FEATURED STORIES
With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
The record-setting government shutdown was just the latest blow to the U.S. biopharma industry. When science funding becomes a casualty of political gridlock, we lose valuable talent, erode public trust and jeopardize our position as a global leader in innovation.
Representatives from companies such as Sanofi and Forge Biologics point to the potential for PreCheck to drive activation of idle production capacity and help companies that are already building plants.
Subscribe to BioPharm Executive
Market insights and trending stories for biopharma leaders, in your inbox every Wednesday
THE LATEST
Biden issued an executive order to keep U.S.-based innovation ahead of advances made by counterparts in China biotechnology and biomanufacturing Monday.
A Manhattan court dismissed a whistleblower lawsuit against Novartis, which had alleged the company paid doctors to promote its multiple sclerosis drug Gilenya.
Pres. Joe Biden vowed to bolster the U.S. biotechnology sector after signing an executive order to improve the fight against cancer.
President Joe Biden tapped Ginkgo Bioworks veteran Renee Wegrzyn to helm the recently-established Advanced Research Projects Agency for Health (ARPA-H).
The FDA is heading into fall with a few Prescription Drug User Fee Act (PDUFA) dates. Here’s a look at this week’s upcoming action.
Although it was a short week due to the Labor Day holiday, the FDA maintained a steady pace of business.
A new report has shed light on some pharmaceutical companies’ attempts to circumvent federal anti-kickback statutes by profiting from large donations to patient assistance organizations.
Wednesday evening, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted 7-2 to recommend approval of Amylyx ALS candidate AMX0035.
Thousands of FDA employees may lose their jobs if Congress doesn’t reappropriate funding currently in place by the end of the month.
The FDA removed the clinical hold on Sarepta’s investigational treatment for certain types of DMD after the company agreed to adjust its clinical trial protocols.